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Topic: FDA

June 6, 2020 |

Silver Spring, MD – The U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

Palm Beach, FL – Rapid development of a vaccine to prevent the global health crisis is a global imperative, and defining the stakes and potential hurdles is critical because regulatory and medical decisions are based on benefit/risk calculations.

The benefit of developing an effective vaccine is very high, and even greater if it can be deployed in time to prevent repeated or continuous epidemics.

Silver Spring, MD – The U.S. Food and Drug Administration has approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology.

Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.

Approval Marks Significant Advance Towards a More Definitive Assessment of Alzheimer’s Based on Brain Imaging

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) took steps on Friday, May 29th, 2020, to further support the development of COVID-19 Coronavirus tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.

Silver Spring, MD – The U.S. Food and Drug Administration continues to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 Coronavirus control measures.